Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-30 @ 9:00 PM
Study NCT ID:
NCT01272661
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2010-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers in Cleveland
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BFS
Brief Summary:
Breast for Success is a new direct service program focused on overcoming barriers to breastfeeding for low-income inner-city mothers by use of a culturally competent and home-based educational and support intervention. Key project components include a new Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and two innovative support plans, the Breastfeeding Doula and Father Support Programs. The objective is to increase breastfeeding rates for high-risk inner-city mothers.
Research Questions to evaluate project feasibility and effectiveness are:
1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?
4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?
Research Questions to evaluate project feasibility and effectiveness are:
1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?
2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?
3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?
4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?
Detailed Description:
Low rates of breastfeeding among low-income inner-city mothers represent a challenging health disparity that adversely impacts child and maternal health. The overall objective of Breast for Success is to increase the rates of breastfeeding initiation, continuation and exclusivity among high-risk mothers in the City of Cleveland via home-based culturally appropriate interventions. Key project components include a new Curriculum with brief engaging modules utilizing games, teach-reteach strategies, and interactive learning to address specific barriers identified in focus groups (e.g. pain, low milk supply, breast "myths"), and two innovative support components, the Breastfeeding Doula and Father Support Programs. Breast for Success was developed in collaboration with and will be disseminated in partnership with the Cleveland Department of Public Health MomsFirst initiative (a Healthy Start Program), which delivers comprehensive services including twice-monthly Community Health Worker home visits prenatally through 2 years postpartum to 500 women annually. The investigators will measure program success via participation logs, satisfaction questionnaires and breastfeeding rates at 1, 3 and 6 months postpartum.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: